Evidence map›Paper›PMID 38739076›Full record

ReviewExpert opinion on drug metabolism & toxicology2024

New approach methods on the bench side to accelerate clinical trials during pregnancy.

Ramkumar Menon, Lauren Richardson, Ananth Kumar Kammala

Abstract readReview
In one paragraph

Review in Expert opinion on drug metabolism & toxicology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Therapeutic potential of extracellular vesicles for treating human pregnancy disorders.Extracellular vesicles and circulating nucleic acids · 2025
    Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Ramkumar MenonDivision of Basic Science and Translational Research, Department of Obstetrics & Gynecology, The University of Texas Medical Branch at Galveston, Galveston, TX, USA.
Lauren RichardsonDivision of Basic Science and Translational Research, Department of Obstetrics & Gynecology, The University of Texas Medical Branch at Galveston, Galveston, TX, USA.
Ananth Kumar KammalaDivision of Basic Science and Translational Research, Department of Obstetrics & Gynecology, The University of Texas Medical Branch at Galveston, Galveston, TX, USA.

Funding

Single cell, multi-parametric high throughput platform to classify endocrine disruptor potential of mixturesP42ES027704 · NIEHS · TEXAS A&M UNIVERSITY · PI Weihsueh A Chiu · 2017 to 2026
$21.2M
Intercellular interactions define cell migrations and transitions that maintain fetal membrane homeostasisR01HD100729 · NICHD · UNIVERSITY OF TEXAS MED BR GALVESTON · PI HAN, ARUM, MENON, RAMKUMAR · 2020 to 2024
$2.6M
Developing trimester-specific placenta organ-on-chips to model healthy and oxidative stress and inflammation-associated pathologiesR01HD110400 · NICHD · UNIVERSITY OF TEXAS MED BR GALVESTON · PI Lauren Stafford Richardson · 2023 to 2026
$2.3M
Investigating the molecular mechanism of P-gp/NHERF-1 network at feto maternal interface and role of paracrine signaling of EVs containing drug transporter proteinsR01HD113193 · NICHD · UNIVERSITY OF TEXAS MED BR GALVESTON · PI KAMMALA, ANANTH KUMAR · 2023 to 2025
$914k
NICHD NIH HHS R01 HD100729NICHD NIH HHS R01 HD110400NICHD NIH HHS R01 HD113193NIEHS NIH HHS P42 ES027704
6 · The paper itself

Abstract

introductionPregnant women are therapeutic orphans as they are excluded from clinical drug development and therapeutic trials. We identify limitations in conducting clinical trials and propose two 'New Approach Methods'(NAMs) to overcome them. AREAS COVERED: NAMs have proven invaluable tools in basic and clinical research to understand human health and disease better, elucidate mechanisms, and study the efficacy and toxicity of therapeutics that have not been possible through animal-based methodologies. The lack of humanized experimental models of FMi and drugs that can safely and effectively cross FMi to reduce the risk of adverse pregnancy has hindered progress in the field of reproductive pharmacology. This report discusses two technological advancements in perinatal research and medicine to accelerate clinical trials during pregnancy. (1) We have developed a humanized microphysiologic system, an Organ-on-a-chip (OOC) platform, to study FMi and their utility in pharmacological studies, and (2) use of extracellular vesicles (EVs) as drug delivery vehicles that are immunologically inert and can cross the fetomaternal barriers. EXPERT OPINION: We provide an overview of NAMs that can accelerate preclinical trials and develop drugs to cross the feto-maternal barriers to reduce the risk of adverse pregnancy outcomes like preterm birth.

Indexed as

Clinical Trials as TopicDrug Delivery SystemsDrug DevelopmentPregnancy ComplicationsPregnancy OutcomeAnimalsExtracellular VesiclesFemaleHumansLab-On-A-Chip DevicesMaternal-Fetal ExchangePregnancyPremature BirthExosomesorgan on chipperinatal medicinepreterm birthreproductive pharmacology

Identifiers

PMID38739076
PMCPMC11929543

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.